American Surgical Delicot Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling 409 boxes of Delicot sponges because defective packaging may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
American Surgical Company is recalling 409 boxes of American Surgical Delicot 13 mm x 60 mm sponges (Ref Number: 63-08). These neurosurgical and nonneurosurgical sponges are being recalled because the product packaging is defective, which may compromise the sterility of the devices.
The affected lots include 2015/09 AK, 2015/09 BS, 2015/10 AY, 2015/10 BO, 2015/11 BF, 2015/12 AC, 2015/12 CI, 2015/12 CS, and 2015/12 CX. The products were distributed worldwide, including in the United States, Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities and consumers should stop using these sponges and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Hazard
- Affected units
- 409
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 91 recalled by American Surgical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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